Retrospective multicenter cohort analysis of 621 cases of BellaGel silicone breast implants with study of physicochemical properties and surface topography

An Ultrasound-Assisted Approach to an Early Detection of Complications of an Implant-Based Augmentation Mammaplasty using the BellaGel® SmoothFine: Preliminary 3-year Clinical Experience

“…Of these, CC occurred at an incidence of 8.8%. This is noteworthy because manufacturer-sponsored retrospective studies have shown incidences of 0.0% (0/239), 0.6% (1/78) and 1.6% (10/621) in patients receiving the BellaGel® implants including the BellaGel® SmoothFine [14,19,20]. Interestingly, another manufacturer-sponsored experimental study compared the vulnerability to CC based on surface properties between the BellaGel® implants, including the BellaGel® SmoothFine, and the Motiva Ergonomix TM SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica), thus drawing conclusions that the BellaGel® SmoothFine was the least vulnerable to CC of the sample devices [18].…”

“…Of note, the safety profile of the BellaGel® SmoothFine has been shown to be non-inferior to that of its competitors [18][19][20]. But these reports are from manufacturer-sponsored studies.…”

“…A recent article revealed that a Korean manufacturer of a silicone gel-filled breast implant, the BellaGel® SmoothFine (HansBiomed Co. Ltd., Seoul, Korea), committed a medical device fraud in violation of the regulatory requirement enforced by the Korean Ministry of Food and Drug Safety (KMFDS) [21]. Interestingly, the BellaGel® SmoothFine has been described as a competitor of the Motiva Ergonomix™ (Establishment Labs Holdings Inc., Alajuela, Costa Rica); its superiority or non-inferiority to other brands of a silicone gel-filled breast implant have been reported in manufacturer-sponsored studies [18][19][20]22]. The manufacturer's violation of the regulatory requirement should be considered serious not only because the BellaGel® SmoothFine is one of the most popular brands of a microtextured device in Korea but also because it has been exported to over 30 countries worldwide as a CE-certified device [21].…”

Association of the BellaGel® Breast Implant Scandal with the Poly Implant Prothèse Fraud: A Review of Literatures

“…The BellaGel ® was first developed in 2005 and then approved by the CE in 2008; it has become commercially available in 30 countries worldwide [26]. Previous studies have described the efficacy and safety of the BellaGel ® [24][25][26][27][28][29]. Of these, a recent study showed that its safety profile was the most excellent among the six different brands of a silicone gel-filled breast implant [28].…”

“…But the KMFDS, the HansBiomed Co. Ltd. and surgeons shared the same opinions on the safety of the BellaGel ® implants; a finished product of the BellaGel ® would not pose serious risk to human health [36]. The safety of the BellaGel ® implants has been well described in six manufacturersponsored studies whether they are prospective or retrospective in nature [25][26][27][28][29]85]. The HansBiomed Co. Ltd. even sponsored a 10-year prospective study and reported 6-year results.…”